Can Glucose Monitoring Improve (CGMi Study)

Consistent CGM use in youth with T1D has been difficult to sustain historically. Youth with
T1D and their families have routinely felt burden related to the introduction of this
technology into their care management. Additionally, there can be difficulties with
calibration, skin irritation, frequent skips, excessive or nuisance alarms and inaccurate
readings which often lead to diminished use or discontinuation entirely. The purpose of this
protocol is to implement and evaluate a family-focused behavioral teamwork intervention aimed
at overcoming barriers to sustained CGM use in youth with T1D. In this 2-year RCT, we will
assess the long-term acceptability and durability of CGM use and its associated glycemic and
psychological outcomes in youth with T1D and their families. We will randomize 120 families
to one of two groups: (1) CGM implemented according to usual care (CGM-Usual Care, CGM-UC) or
(2) CGM implemented with a family teamwork intervention (CGM-Teamwork, CGM-TW). This
intervention will allow participants and families to overcome barriers to sustained CGM use
and achieve glycemic benefits that have been afforded to adults using CGM as demonstrated in
other research. In year 1, all CGM supplies will be provided and covered by study resources.
In year 2, study participants will be asked to cover the costs associated with sensor use and
any costs associated with replacement of CGM components in a manner consistent with routine
clinical care as the investigators believe that it is important to assess durability of CGM
use in clinical practice.

Inclusion Criteria:

- Age 8-17 years

- Planning to be living at home for 2 years

- Type 1 diabetes of at least 1 year duration

- Daily insulin dose ≥0.5 units/kg

- A1c ≥6.5% and ≤10.0%

- Insulin therapy with continuous subcutaneous insulin infusion (CSII) or multiple daily
injections (≥3 injections/day)

- Blood glucose (BG) monitoring frequency ≥4 times/day

- Agreement to wear a CGM device

- Fluency in English for child and parent/guardian

- Stable living situation for ≥6 months (e.g., no Department of Youth Services
Involvement)

- Joslin Clinic attendance: At least one Joslin Clinic visit in last year AND
Anticipated care at Joslin Clinic for duration of study

Exclusion Criteria:

- Consistent CGM use, defined as 6+ days/week during the previous 6 months

- History of severe, life-threatening skin reactions to the adhesive used with the CGM
device

- Pregnancy in the youth participant or intention to become pregnant within the next 2
years

- Significant developmental or cognitive disorder in the youth or parent/guardian that
would prevent full participation in a family-based, behavioral intervention or
implementation of CGM

- Inpatient psychiatric admission within the previous 6 months

- Participation in another intervention study during the previous 3 months

- Intent to enroll in another intervention study during the study period